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510(k) K923218

NITANIUM PALATAL EXPANDER by Ortho Organizers, Inc. — Product Code EJF

K923218 is an FDA 510(k) premarket notification submitted by Ortho Organizers, Inc. for the device "NITANIUM PALATAL EXPANDER". The FDA issued a decision of Substantially Equivalent on September 13, 1993. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ortho Organizers, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1993
Date Received
July 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Ortho Organizers, Inc.

  • K252760 — Carriere® Motion Pro® Clear Bite Corrector (November 27, 2025)
  • K173440 — Carriere SLX 3D Clear (March 8, 2018)
  • K160720 — Carriere Motion Clear Class II (November 28, 2016)
  • K110335 — CERAMIC BRACKETS (May 19, 2011)
  • K061266 — ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR (July 31, 2006)
  • K931980 — STAINLESS STEEL ORTHODONTIC PRODUCTS (September 1, 1993)
  • K931663 — NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL (July 8, 1993)

Other clearances for product code EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K923372 — MEMORY WIRE (April 22, 1994)
  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources